MATRACELL DECELLULARIZED PULMONARY ARTERY PATCH ALLOGRAFT


Device Classification Name

patch, pledget and intracardiac, petp, ptfe, polypropylene

510(k) Number K081438
Device Name MATRACELL DECELLULARIZED PULMONARY ARTERY PATCH ALLOGRAFT
Applicant
LifeNet Health
1864 concert dr.
virginia beach, 
VA 
23453

Applicant Contact alyce linthurst jones
Correspondent
LifeNet Health
1864 concert dr.
virginia beach, 
VA 
23453

Correspodent Contact alyce linthurst jones
Regulation Number 870.3470
Classification Product Code
DXZ  
Date Received 05/22/2008
Decision Date 10/17/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No